Dental CariesNCT04136639
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
A study testing Miswak, Grape Seed Extract Mouthwash and fluoride in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Prevention of dental caries has taken a great importance in the last decade. The use of herbal and natural products became mandatory to avoid the side effects of commercially available medications. Aim of the study; the aim was to investigate the anti-cariogenic effect of miswak and grape seed extract (GSE). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Miswak, Grape Seed Extract Mouthwash and fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with high caries risk
- Males or females
- Medically free patients
- Patients approving to participate in the study
Who cannot join
- Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
- Patients had history of professional cleaning in the last 15 days
- Patients with exposed pulp
- Evidence of parafunctional habits
- Patients with developmental dental anomalies
- Patients undergoing or will start orthodontic treatment
- Patients with removable prosthesis
- Periapical Abscess or Fistula
Trial locations and contacts
1 site in 1 country.
About this study
Prevention of dental caries has taken a great importance in the last decade. The use of herbal and natural products became mandatory to avoid the side effects of commercially available medications. Aim of the study; the aim was to investigate the anti-cariogenic effect of miswak and grape seed extract (GSE).
Read the detailed description
Patients used Miswak sticks, grape seed extract mouth wash and fluoride mouthwash twice daily for three month. Saliva samples were collected at base line and after one month and three month. Assessment of bacterial count and saliva buffering capacity were performed at base line and after one and three month.
- Conditions
- Dental Caries
- Being tested
- Miswak, Grape Seed Extract Mouthwash, fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiswakOther
Also called silvadora persica
sticks
Grape Seed Extract MouthwashOther
Also called 95% proanthocyanidins
Mouthwash
fluorideOther
Also called 0.05% sodium fluoride
mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Miswak | Experimental | Miswak sticks used twice daily, every 12 hours, for three months. Receives: Other: Miswak |
| Grape Seed Extract | Experimental | Grape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months. Receives: Other: Grape Seed Extract Mouthwash |
| Fluoride Mouthwash | Active comparator | 0.05% fluoride mouthwash used twice daily, every 12 hours, for three months. Receives: Other: fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months.
the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline,after one month and after three months. Every time samples were incubated with Mitiis Salivaris with Bacitricin and 20% sucrose for streptococcus mutans count.
Measured: Baseline, one month, three months.
Secondary outcomes (1)
quantitative measure of the change in saliva buffering capacity from baseline to one month and three months.
the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline, after one month and after three months. each time, saliva buffering capacity was measured using Hand Held pH meter and 0.1 mol/l hydrochloric acid that was titrated to the tested saliva.
Measured: baseline, one month , three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Jun 2019
- Primary completion31 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Ahmed Abdel Moneim, Al-Azhar University
- Investigators
- Maha Niazy, Professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136639
- Sponsor's protocol ID
- REC17-082
- Status last verified
- Oct 2019
- First submitted
- 19 Oct 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
- ClinicalTrials.gov ID
- NCT04136639
- Acronym / sponsor ID
- REC17-082
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevention of dental caries has taken a great importance in the last decade. The use of herbal and natural products became mandatory to avoid the side effects of commercially available medications. Aim of the study; the aim was to investigate the anti-cariogenic effect of miswak and grape seed extract (GSE).
Detailed description
Patients used Miswak sticks, grape seed extract mouth wash and fluoride mouthwash twice daily for three month. Saliva samples were collected at base line and after one month and three month. Assessment of bacterial count and saliva buffering capacity were performed at base line and after one and three month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Miswak | Experimental | Other: MiswakMiswak sticks used twice daily, every 12 hours, for three months. |
| Grape Seed Extract | Experimental | Other: Grape Seed Extract MouthwashGrape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months. |
| Fluoride Mouthwash | Active comparator | Other: fluoride0.05% fluoride mouthwash used twice daily, every 12 hours, for three months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with high caries risk
- Males or females
- Medically free patients
- Patients approving to participate in the study
Key exclusion criteria (8 listed)
- Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
- Patients had history of professional cleaning in the last 15 days
- Patients with exposed pulp
- Evidence of parafunctional habits
- Patients with developmental dental anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiswakAlso: silvadora persicasticks | Other | Miswak |
| Grape Seed Extract MouthwashAlso: 95% proanthocyanidinsMouthwash | Other | Grape Seed Extract |
| fluorideAlso: 0.05% sodium fluoridemouthwash | Other | Fluoride Mouthwash |
Primary outcome
quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months.
Time frame: Baseline, one month, three months.
the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline,after one month and after three months. Every time samples were incubated with Mitiis Salivaris with Bacitricin and 20% sucrose for streptococcus mutans count.
1 secondary outcome
quantitative measure of the change in saliva buffering capacity from baseline to one month and three months.
Time frame: baseline, one month , three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Niazy, Professor study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miswak, Grape Seed Extract Mouthwash and fluoride in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months. (time frame: Baseline, one month, three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.